OriGen recalls Reinforced Dual Lumen Cannula (23Fr, REF VV23F) due to possible barium sulfate omission and shorter catheter tip than labeled. This may affect extracorporeal life support procedures.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
OriGen is recalling Reinforced Dual Lumen Cannulas that may lack barium sulfate and have a shorter tip than printed. This could cause issues during critical extracorp: 1) improper blood drainage, 2) potential blockage in life support systems.
The cannula may lack barium sulfate, which is critical for certain medical procedures. The tip is also one centimeter shorter than labeled, potentially causing improper blood flow or blockages during life support.
Healthcare professionals using these cannulas for extracorporeal life support procedures. Patients on such life support systems are most at risk if the cannula fails.
Check for the product name 'Reinforced Dual Lumen Cannula', size 23Fr, reference number VV23F, and lot numbers N18431 or N18431-1. These were sold with UDI 00816203022103.
Verify the product name, size, reference number, and lot numbers to confirm if it's affected.
The cannula may lack barium sulfate and have a shorter tip than printed, which could cause improper blood drainage or blockages during extracorporeal life support procedures.
Check the product details to confirm if it's affected; the recall does not specify a remedy.
The recall indicates potential issues with blood drainage and blockages, but no specific serious injury risk is stated.
We’ve drafted a message you can send OriGen to request your refund or repair — edit it as you like.
Subject: Recall Z-0182-2019 — OriGen OriGen Hello, I own a OriGen that is covered by recall Z-0182-2019 from OriGen. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
